■ Lawmakers are questioning why the FDA hasn't regulated the industry more aggressively.

Washington -- Results of consumer genetic tests are unreliable, and marketers of such tests sometimes overstate their value in order to sell other products and services, according to an undercover Government Accountability Office investigation unveiled July 22 at a House subcommittee hearing.

Test results from four direct-to-consumer genetic testing companies varied widely for the same person, according to the GAO report. For example, one 48-year-old male was informed that his risk for developing prostate cancer was below average in one company's test, average in two other tests, and above average in a fourth.

"These tests are not ready for prime time," said Gregory Kutz, managing director of GAO's Forensic Audits and Special Investigations Unit. "Genetic testing for diseases appears to be more of an art than a science."

The increasingly bolder marketing tactics of direct-to-consumer genetic testing could lead to tighter Food and Drug Administration control over the industry, according to Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health.

Members of the House Energy and Commerce oversight subcommittee praised recent advances in genetic research while questioning the value of the consumer genetic tests. Energy and Commerce Chair Henry Waxman (D, Calif.) asked if consumers would lose any benefits if new regulations forced the companies out of business.

Representatives from three major consumer genetic testing companies testified at the hearing. None were able to review GAO testimony in advance, which is a routine courtesy for congressional committee panelists.

The differing genetic test results were probably due to different methods of interpreting the genetic markers, testified Ashley Gould, general counsel for 23andMe, one of the companies investigated by the GAO. Gould said 23andMe believes its customers can rely on its interpretations.

However, Gould also said the tests are for informational and educational use. Customers should seek medical advice from physicians and genetic counselors, she said. The firm is also interested in working with the FDA and National Institutes of Health on universal guidelines for interpreting genetic tests.

"You're right. We need standards," said oversight subcommittee Chair Bart Stupak (D, Mich.). "Hopefully from this hearing we will move along with that."

Rep. Parker Griffith, MD (R, Ala.), leveled perhaps the harshest criticism at the companies. Dr. Griffith said no one is more vulnerable to medical fraud than an individual concerned about his or her family's history of disease. "This is nothing more than a snake oil salesman revisited again in a high-tech way."

American Medical Association policy calls for fully counseling patients about the process of genetic testing for more than one condition, including on its degree of uncertainty.

FDA: "We should have acted sooner"

The FDA has monitored direct-to-consumer genetic testing companies for years, Dr. Shuren said. When the agency met with genetic testing companies in 2007, many tests focused on determining ancestry, Dr. Shuren said. Now consumer genetic testing companies claim they can gauge a person's genetic compatibility with cancer drugs and his or her likelihood of developing diseases.

The FDA has not approved any of the direct-to-consumer genetic tests, Dr. Shuren said. The FDA has sent letters to companies asking them to stop selling consumer genetic tests in stores because the agency considers them to be unapproved medical devices. Discussions with the companies continue, he said.

The GAO investigation found that one genetic testing company's telephone representative -- secretly recorded by the oversight agency -- said one female subject's test showed she was "in the high risk of pretty much getting" breast cancer.

ADDITIONAL INFORMATION

Consistency of consumer genetic tests

Click to see data in PDF.

A Government Accountability Office investigation released July 22 found that direct-to-consumer genetic testing kits provided widely varying results. Different kits returned contrasting assessments of the degrees to which patients were at risk for developing a disease.

Test

Company 1

Company 2

Company 3

Company 4

Female, 37

Leukemia

Above average

Below average

Average

Not tested

Breast cancer

Average

Above average

Average

Above average

Female, 41

Type 1 diabetes

Above average

Above average

Below average

Not tested

Restless leg syndrome

Below average

Above average

Not tested

Average

Male, 48

Prostate cancer

Average

Average

Below average

Above average

Hypertension

Average

Below Average

Above average

Not tested

Male, 61

Celiac disease

Above average

Average

Not tested

Above average

Multiple Sclerosis

Below Average

Average

Average

Below Average

Male, 63

Heart attack

Average

Above average

Above average

Average

Atrial fibrillation

Average

Below Average

Average

Average

Source: "Direct-To-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices," Government Accountability Office, July 22 (link)